Generic Actos Approved Amid Lawsuits Over Bladder Cancer Warnings

Despite growing concerns about the adequacy of warnings about the risk of bladder cancer from Actos side effects, the FDA approved the first generic version of the popular diabetes drug last week. 

Mylan Pharmaceuticals received permission to market generic Actos (pioglitazone) tablets in 15, 20 and 45 mg strength.

The diabetes drug will carry the same warnings currently placed on the medication by the maker of the brand name version, Takeda Pharmaceuticals, including a boxed warning that it may cause or worsen heart failure, and a warning added last year that taking pioglitazone for more than one year may be associated with an increased risk of bladder cancer.

Those same warnings are currently the subject of hundreds of Actos lawsuits filed in courts throughout the United States, which allege that Takeda has failed to provide sufficient information to consumers and the medical community about the risk of problems. Some of the complaints suggest that the bladder cancer risks outweigh the benefits provided by the diabetes drug, and that an Actos recall should have already been issued.

Actos (pioglitazone) was developed by Takeda Pharmaceuticals and approved in the United States for treatment of type 2 diabetes in July 1999.  It is a once-daily pill that increases the body’s sensitivity to insulin.  Related medications that also contain the same active pharmaceutical ingredient include ActoPlus Met and Duetact.

Concerns about the potential link between bladder cancer and Actos surfaced in September 2010, after the FDA reported that they were investigating the potential risk based on interim data from an on-going study, which found an increased incidence of bladder tumors among users of Actos.

French insurers conducted their own study and provided the first evidence of a link between Actos and bladder cancer. This led to a recall for Actos in France and Germany, and new label warnings elsewhere.

Takeda faces product liability lawsuits filed on behalf of individuals throughout the United States who were diagnosed with bladder cancer after using Actos, alleging that the drug maker failed to provide adequate warnings about the risks associated with long-term use of the medication. Many complaints allege that the current Actos warnings remain insufficient.

Earlier this month a new study on the Actos bladder cancer risk found that those who took pioglitazone for less than five years may face double the risk of bladder cancer and those who took it for longer than five years may face triple the risk.

All federal lawsuits over Actos have been consolidated as part of an MDL, or multidistrict litigation (MDL), which is centralized before U.S. District Judge Rebecca Doherty in the Western District of Louisiana for pretrial proceedings. The first Actos trials over the warning label are scheduled for November 2014 and January 2015.